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Monoclonal Antibodies
AZD5863 for Advanced Solid Cancers
Phase 1 & 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a new drug can safely and effectively treat advanced solid tumors. #CancerResearch
Who is the study for?
Adults over 18 with advanced solid tumors like pancreatic, esophageal, or stomach cancer can join this trial if they've had at least one prior treatment for advanced cancer. They need a life expectancy of 12 weeks or more, measurable tumor lesions, and positive CLDN18.2 expression in their tumor cells. Good physical health is required (ECOG PS: 0-1), as well as proper organ and bone marrow function.
What is being tested?
The study tests AZD5863, an experimental drug that targets specific proteins on T cells and cancer cells to fight the tumor. It's given to see if it's safe and effective against certain types of solid tumors that have spread or cannot be removed by surgery.
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as cytokine release syndrome (CRS) which can cause fever and fatigue; neurotoxicity; inflammation-related symptoms affecting different organs; infection risks due to immune response changes; plus common drug-related adverse events.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The number of patients with adverse events
The number of patients with adverse events of special interest
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
+1 moreSecondary study objectives
Disease Control Rate (DCR)
Duration of response (DoR)
Immunogenicity of AZD5863
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Module 2: AZD5863 Monotherapy Subcutaneous (SC)Experimental Treatment1 Intervention
Module 2: AZD5863 Subcutaneous (SC) Monotherapy
Group II: Module 1: AZD5863 Monotherapy Intravenous (IV)Experimental Treatment1 Intervention
Module 1: AZD5863 Intravenous (IV) Monotherapy
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,252 Total Patients Enrolled